Commission Regulation (EC) No 109/2007 of 5 February 2007 concerning the authorisation of monensin sodium (Coxidin) as a feed additive (Text with EEA relevance )
Date: 2007-02-05
Institutions: European Commission
Subjects: animal feedingstuffs, food additive, food safety, market approval, poultry, zootechnics

L 31/6

EN

Official Journal of the European Union

6.2.2007

COMMISSION REGULATION (EC) No 109/2007

of 5 February 2007

concerning the authorisation of monensin sodium (Coxidin) as a feed additive

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1831/2003 of
European Parliament and of
the Council of 22 September
2003 on additives for use in animal nutrition (1), and in
particular Article 9(2) thereof,

Whereas:

(1)

(2)

(3)

(4)

Regulation (EC) No 1831/2003 provides for the author-
isation of additives for use in animal nutrition and for
the grounds and procedures for granting such author-
isation.

In accordance with Article 7 of Regulation (EC) No
1831/2003, an application was submitted for the author-
isation of the preparation set out in the Annex to this
Regulation. That application was accompanied by the
particulars and documents required under Article 7(3)
of that Regulation.

The application concerns authorisation of the substance
monensin sodium (Coxidin) as a feed additive for
chickens for fattening and turkeys, to be classified in
the additive category ‘occidiostats and histomonostats’.

The European Food Safety Authority (the Authority)
concluded in its opinion of 20 October 2005 that
monensin sodium (Coxidin) does not have an adverse
effect on animal health, human health or
the en-
vironment (2). The Authority further concluded that
monensin sodium (Coxidin) does not present any other
risk which would,
in accordance with Article 5(2) of
Regulation (EC) No 1831/2003, exclude authorisation.
According to that opinion, the use of that product may
be effectively used to prevent coccidiosis. This opinion
also verified the report on the method of analysis of that

feed additive in feed submitted by the Community
Reference Laboratory set up by Regulation (EC) No
1831/2003. The Authority concluded that
it was
necessary to establish maximum residue limits (MRLs).
However,
it was unable to propose MRLs since the
applicant had not provided the data required. After
receiving those data the Authority adopted an opinion
proposing provisional MRLs on 21 November 2006 (3).
It may be necessary to review the MRLs set out in the
Annex to this Regulation in the light of the results of a
future evaluation of the active substance concerned by
the European Agency for the Evaluation of Medicinal
Products.

that preparation shows

The assessment of
the
conditions for authorisation, provided for in Article 5
of Regulation (EC) No 1831/2003,
satisfied.
Accordingly,
that preparation should be
the use of
authorised, as specified in the Annex to this Regulation.

that

are

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

(5)

(6)

HAS ADOPTED THIS REGULATION:

Article 1

The substance, specified in the Annex, belonging to the additive
category ‘coccidiostats and histomonostats’, is authorised as an
additive in animal nutrition subject to the conditions laid down
in that Annex.

Article 2

This Regulation shall enter into force on the 20th day following
the European
that of
Union.

its publication in the Official

Journal of

(1) OJ L 268, 18.10.2003, p. 29. Regulation as

amended by
Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005,
p. 8).

(2) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed on a request from the European
the coccidiostat COXIDIN (monensin sodium),
Commission of
adopted on 20 October 2005, The EFSA Journal
(2005) 283,
p. 1-53.

(3) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed on the Maximum Residues Limits
for monensin sodium for chicken and turkeys for fattening, adopted
on 21 November 2006, The EFSA Journal (2006) 413, p. 1-13. See
also opinion of the Scientific Panel on Additives and Products or
Substances used in Animal Feed on the safety of COXIDIN
(monensin sodium), adopted on 12 July 2006, The EFSA Journal
(2006) 381, p. 1-10.

6.2.2007

EN

Official Journal of the European Union

L 31/7

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 5 February 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 31/8

EN

Official Journal of the European Union

6.2.2007

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